Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DOXAZOSIN MESILATE
Clear Pharmacy
C02CA04
DOXAZOSIN MESILATE
4 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists
Authorised
2010-11-05
PACKAGE LEAFLET: INFORMATION FOR THE USER CARDURA™ XL 4MG CARDURA™ XL 8MG PROLONGED–RELEASE TABLETS doxazosin (as mesilate) IMPORTANT THINGS THAT YOU SHOULD KNOW ABOUT YOUR MEDICINE: • Cardura XL is a treatment for high blood pressure. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • You should take Cardura XL regularly to get the maximum benefit, even if you are feeling well. • Most people do not have serious problems when taking Cardura XL but side effects can occur – see Section 4 for details. If you experience swelling of the face, tongue or windpipe, see your doctor immediately. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. • Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other medicines. • If you are, or are trying to become, pregnant, do not take Cardura XL and tell your doctor. Please read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important to you. If you have any further questions, ask your doctor or pharmacist. IN THIS LEAFLET: 1. What Cardura XL is and what it is used for 2. Before you take Cardura XL 3. How to take Cardura XL 4. Possible side effects 5. How to Store Cardura XL 6. Further information 1. WHAT CARDURA XL IS AND WHAT IT IS USED FOR Cardura XL is one of a group of medicines called alpha-blockers. It is used to treat high blood pressure. Cardura XL can be used to treat high blood pressure (hypertension), by relaxing blood ves Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardura XL 4mg Prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4mg doxazosin (as mesilate) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. _Product imported from UK:_ Cardura XL 4mg prolonged-release tablets are white, round, biconvex shaped tablets with an orifice on one side, marked 'CXL4'. 4 CLINICAL PARTICULARS As per PA0822/004/001 5 PHARMACOLOGICAL PROPERTIES As per PA0822/004/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Polyethylene oxide Sodium chloride Hypromellose Red ferric oxide (E 172) Titanium dioxide (E 171) Magnesium stearate Cellulose acetate Macrogol Pharmaceutical glaze Black iron oxide (E 172) Ammonium hydroxide Propylene glycol 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer packaging of the product on the market in the country of origin. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 16/10/2014_ _CRN 2132369_ _page number: 1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Opaque blisters in a cardboard carton. Calendar packs of 28 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Clear Pharmacy 157-173 Roden Street Belfast, UK BTl25QA 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1596/024/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF TH Prečítajte si celý dokument